Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
After surgery to remove brain metastasis, patients are usually given whole brain
radiotherapy because of the risk of the tumor regrowing in that area or in other places in
the brain. It is given in 10-14 daily sessions over 2-3 weeks. Because of the potential
side effects of whole brain radiotherapy, stereotactic radiosurgery to the area of the brain
with metastasis or observation is also used.
This study will be using stereotactic radiosurgery or observation instead of whole brain
Stereotactic radiosurgery is a highly focused, 1 day outpatient radiation procedure.
Observation is checking the brain through repeat magnetic resonance imagine (MRI) scans, but
performing no treatment.
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups.
- Group 1 will receive stereotactic radiosurgery to the area of the brain that had the
brain metastasis removed.
- Group 2 will be observed with routine MRI scans only.
You will have an equal chance of being assigned to either group.
Stereotactic radiosurgery will be offered for treatment of any tumor that was not removed by
surgery whether or not you are randomized to treatment of the surgical bed or not.
If you are assigned to receive stereotactic radiosurgery, your neurosurgeon and radiation
oncologist will discuss the procedure with you in detail. You will also sign a separate
consent form, which will include the potential risks.
Stereotactic radiosurgery requires the placement of a stereotactic head frame, which is a
ring attached to the head with 4 small pins. The frame placement is done with local
anesthetic (numbing medicine) by the neurosurgeon on the day of the procedure and will
remain in place until the end of the stereotactic radiosurgery later in the day. The
stereotactic frame will help the doctor to target the radiotherapy to the area of the
surgery that was found by an MRI scan. The surgical area and up to 2 other lesions will be
You will have standard MRI scans of the brain after surgery, at 5-8 weeks after surgery,
every 6-9 weeks for a year, and then every 3-4 months after that. At these times, the area
of surgery and any other brain tumors that were treated will be evaluated for regrowth or
side effects from the treatment. The doctors will also decide whether there are any new
lesions that require treatment.
Length of Study:
You will be considered to be off study if the tumor has returned to the surgery site or if
whole brain radiotherapy is used.
This is an investigational study. Stereotactic radiosurgery is FDA approved and
commercially available. The comparison of stereotactic radiosurgery to observation is
Up to 132 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Local Recurrence (TTLR)
Differences in TTLR will be monitored at 3 timepoints and will take place: 1) after a total of 39 events occur; 2) after 77 events occur; and 3) after at least 115 events occur.
Anita Mahajan, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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